The US Food and Drug Administration (FDA) has approved the first generic version of lenacapavir, the highly effective twice-yearly injection to prevent HIV, developed by Dr Reddy’s Laboratories based in India.

Dr Reddy’s was one of six pharmaceutical manufacturers that was granted a non-exclusive, royalty-free voluntary licensing agreement from Gilead, which developed lenacapavir.

The agreement, signed in October 2024, limits the sale of the generics to 120 high-incidence, resource-limited countries.

The generics – projected to cost $40 a year for the two injections – are expected to reach countries by the end of this year. Zambia is likely to be one of the first to get supplies. 

Dr Reddy’s Deepak Sapra described the approval as “a moment of immense pride” for the company.

“Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities, manufacturing expertise and the ability to produce at scale,” added Sapra. 

Dr Reddy received “financial, technical, and regulatory support” from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development of the generic. The FDA approval comes only 16 months after Gilead’s product was approved. 

“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” said Dr. Philippe Duneton, Unitaid executive director. 

“Getting a generic approved just 16 months after the originator approval for prevention, rather than a decade later, shows what’s possible when we prioritize access from the start. This should be the new standard for global health,” said CHAI CEO Dr Neil Buddy Shah.

“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” added Shah. 

“More than 125,000 people in Africa have already started on lenacapavir, and today’s approval brings us closer to making it available to millions more for just $40 a year.”

However, Wits RHI’s Professor Saiqa Mullick warned that an affordable generic is not enough: “Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them, and communities that are engaged as partners in their introduction and scale-up. Bringing these elements together will be critical to ensuring equitable access and impact.”

“Unitaid, Wits RHI, and CHAI are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy (GHSD), the Gates Foundation, and other partners to turn approval into access on the ground, from supporting country introduction and community engagement to generating real-world evidence to inform how lenacapavir can best reach diverse and underserved populations,” the three groups noted in a media release on Monday.

Image Credits: @Unitaid.